Bahrain maintains a curious policy requiring that new pharmaceutical
products be on the market for a minimum of 2 years as a condition for
marketing authorization. The apparent objective of the regulation is
to ensure adequate pharmacological efficacy and safety. The rule, however,
far exceeds reasonable safeguards for US and international research-based
pharmaceutical companies. US research based pharmaceutical companies
must meet the stringent and extensive efficacy and safety requirements
of the FDA and/or other major or "primary" reference countries,
e.g., the Medicines Control Agency (MCA) in the United Kingdom, or the
European Medicines Evaluation Agency (EMEA).

The requirement that the medicine be on the market in those countries
for at least two years is not supported by scientific or medical evidence.
Although exceptions are frequently granted, the regulation represents
an unnecessary regulatory impediment to technology transfer and the
introduction of pharmaceutical innovations to Bahraini patients.

The pharmaceutical industry has been informed that Bahrain's patent
laws have been amended recently to ensure TRIPS conformity. PhRMA member
companies, however, have not been successful in attempts to obtain a
copy of the law from the Government, and therefore, can not verify these
claims. In a disturbing development, Bahrain joined other GCC member
states in supporting GCC ministerial resolution No. 11, approved in
February. Despite the fact that Bahrain has provided patent protection
for pharmaceuticals since 1957, Resolution No. 11 calls on GCC states
to implement a 5-year "grace" period for pharmaceuticals,
delaying protection until 2005.

Finally, Bahrain maintains a policy of price controls on pharmaceuticals
which reduces opportunities for market based competition among manufacturers,
distributors, wholesalers and retail pharmacists.

Potential Exports/Foreign Sales

Removal of the 2 year rule for companies demonstrating product registration
in "reference" countries, and implementation of a "fast
track" system for the evaluation of cutting edge medicines, could
lead to the earlier introduction of innovative American pharmaceuticals
and enormous new benefits to patients. PhRMA urges the US government
to reconfirm Bahrain's commitment to product patent protection and a
clarification regarding Bahrain's support for GCC Resolution No. 11.